经阴道内镜与单孔腹腔镜在子宫切除术中的应用比较

doi:10.3877/cma.j.issn.1674-6899.2024.01.010

中华腔镜外科杂志(电子版) ›› 2024, Vol. 17 ›› Issue (01) : 39 -44. doi: 10.3877/cma.j.issn.1674-6899.2024.01.010

论著

经阴道内镜与单孔腹腔镜在子宫切除术中的应用比较

严斌¹, 缪慧娴², 王酉¹, 狄文¹, 楼微华¹^,^†(

)

^1. 200127　上海交通大学医学院附属仁济医院妇产科，上海市妇科肿瘤重点实验室，肿瘤系统医学全国重点实验室
^2. 210029　江苏，南京医科大学第一附属医院

收稿日期:2024-02-01 出版日期:2024-02-28
通信作者: 楼微华
基金资助:
国家重点研发计划(2021YFC2700400); 上海市卫生健康委员会面上项目(202340083); 上海市科委计划项目(23JC1403000); 中国博士后科学基金面上资助(2023M731412)

Comparison of the application of transvaginal natural orifice transluminal endoscopic surgery and trans-umbilical laparoscopic single-site surgery in hysterectomy

Bin Yan¹, Huixian Miao², You Wang¹, Wen Di¹, Weihua Lou¹^,^†()

^1. Department of Obstetrics and Gynaecology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Key Laboratory of Gynaecologic Oncology, State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200217, China
^2. The First Affiliated Hospital with Nanjing Medical University, Jiangsu 210029, China

Received:2024-02-01 Published:2024-02-28
Corresponding author: Weihua Lou

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引用本文：

严斌, 缪慧娴, 王酉, 狄文, 楼微华. 经阴道内镜与单孔腹腔镜在子宫切除术中的应用比较[J/OL]. 中华腔镜外科杂志(电子版), 2024, 17(01): 39-44.

Bin Yan, Huixian Miao, You Wang, Wen Di, Weihua Lou. Comparison of the application of transvaginal natural orifice transluminal endoscopic surgery and trans-umbilical laparoscopic single-site surgery in hysterectomy[J/OL]. Chinese Journal of Laparoscopic Surgery(Electronic Edition), 2024, 17(01): 39-44.

目的

比较经阴道自然腔道内镜手术(transvaginal natural orifice transluminal endoscopic surgery，vNOTES)与经脐单孔腹腔镜手术(trans-umbilical laparoscopic single-site surgery，TU-LESS)应用于子宫切除术的可行性、安全性和疗效。

方法

回顾性分析2019年1月至2021年6月在上海交通大学医学院附属仁济医院接受vNOTES或TU-LESS手术切除子宫的患者。

结果

共纳入361例，其中vNOTES组228例，TU-LESS组129例，4例从vNOTES中转TU-LESS。vNOTES组手术时间短于TU-LESS组[80.76 min vs.112.09 min，平均差－31.34(－40.24，－22.43)min，P<0.001]。vNOTES组手术后肛门排气时间更快[18.80 h vs. 36.49 h，平均差－17.68 (－20.23, －15.14) h，P<0.001]，住院时间更短[2.31 d vs. 3.77 d，平均差－1.46 (－1.75, －1.17)，P<0.001]，术中出血量无增加(中位数50 ml vs. 50 ml，P＝0.25)。此外，vNOTES组术后24 h内的疼痛视觉模拟评分(visual analogue scale，VAS)低于TU-LESS组(中位数0 vs. 0.5分，P<0.001)。通过累计分析确定了四个独特的学习曲线阶段，各阶段平均手术时间分别为阶段Ⅰ82.81±31.45 min(前43例手术技能逐步熟悉)，阶段Ⅱ72.48±23.66 min(后续91例手术技能熟练掌握)，阶段Ⅲ103.77±45.69 min(后续26例手术挑战操作难度)，阶段Ⅳ73.18±26.89 min(68例手术的操作成熟稳健)。

结论

作为一种切除子宫的新型微创手术方式，vNOTES与TU-LESS具有同等效果，可让患者术后恢复更快，减少疼痛。其切除大子宫的安全性和可行性还需进一步探索。

关键词: 腹腔镜下全子宫切除术, vNOTES, TU-LESS, 学习曲线

Objective

To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery(vNOTES) versus trans-umbilical laparoscopic single-site surgery(TU-LESS) as a minimal invasive technique.

Methods

The women undergoing hysterectomy for benign diseases by vNOTES or TU-LESS from Jan. 2019 to Jun. 2021 in a tertiary hospital in Shanghai were retrospectively analyzed.

Results

361 women were included in our study, with 228 in the vNOTES groups, 129 in the TU-LESS groups and 4 conversions from vNOTES to TU-LESS technique. The operation time of vNOTES group was shorter than TU-LESS group(80.76 min versus 112.09 min; MD -31.34 min ; 95%CI -40.24 to -22.43 min; P<0.001). vNOTES hysterectomy has a quicker gas passage by anus(18.80 versus 36.49 hours, MD -17.68 hours, 95%CI -20.23 to -15.14 hours, P<0.001), and associated with a shorter length of hospital stay (2.31 versus 3.77 days, MD -1.46 days, 95%CI -1.75 to -1.17 days, P<0.001), while with no increase in blood loss during the operation (median 50 versus 50 ml, P=0.25). Besides, the VAS pain score in the 24th hour after the operation was lower(median 0 versus 0.5, P<0.001) in the vNOTES group. Four unique phases of the learning curve were identified using cumulative analysis: the mean operation time of phase I was 82.81±31.45 min ( the initial learning curve of 43 cases), phaseⅡwas 72.48±23.66 min ( the acquisition of command of 91 cases), phase Ⅲ was 103.77±45.69 min (the further learning of 26 cases) and phase Ⅳ was 73.18±26.89 min ( post learning in 68 cases).

Conclusion

vNOTES is non-inferior to TU-LESS as a new minimal invasive procedure for hysterectomy, which also allows patients a faster recovery from surgery and to suffer less pain, and its efficiency and feasibility in large uterine needs further exploring.

Key words: Laparoscopic hysterectomy, vNOTES, TU-LESS, Learning curve

表1 vNOTES组和TU-LESS组基本信息

	vNOTES^a(n＝228)	TU-LESS(n＝129)	P值
年龄(岁)	53.04±9.44	54.26±10.33	0.27
BMI(kg/m²)	23.96±3.08	24.26±3.84	0.48
既往阴道分娩[n(%)]	155(67.98)	80(62.02)	0.25
既往腹部手术史[n(%)]	84(36.84)	59(45.74)	0.10
心血管疾病[n(%)]	41(17.98)	32(24.81)	0.13
糖尿病[n(%)]	13(5.70)	5(3.88)	0.45
手术指征[n(%)]
子宫内膜不典型增生	16(7.02)	5(3.91)	0.23
子宫肌腺病	36(15.79)	13(10.16)	0.13
子宫肌瘤	84(36.84)	62(48.44)	0.04
高级别宫颈上皮内病变	68(29.82)	18(14.07)	<0.001
难治性DUB	2(0.88)	4(3.13)	0.20
良性附件肿物	11(4.82)	26(20.16)	<0.001
子宫脱垂	11(4.82)	1(0.78)	0.02

表1 vNOTES组和TU-LESS组基本信息

	vNOTES^a(n＝228)	TU-LESS(n＝129)	P值
年龄(岁)	53.04±9.44	54.26±10.33	0.27
BMI(kg/m²)	23.96±3.08	24.26±3.84	0.48
既往阴道分娩[n(%)]	155(67.98)	80(62.02)	0.25
既往腹部手术史[n(%)]	84(36.84)	59(45.74)	0.10
心血管疾病[n(%)]	41(17.98)	32(24.81)	0.13
糖尿病[n(%)]	13(5.70)	5(3.88)	0.45
手术指征[n(%)]
子宫内膜不典型增生	16(7.02)	5(3.91)	0.23
子宫肌腺病	36(15.79)	13(10.16)	0.13
子宫肌瘤	84(36.84)	62(48.44)	0.04
高级别宫颈上皮内病变	68(29.82)	18(14.07)	<0.001
难治性DUB	2(0.88)	4(3.13)	0.20
良性附件肿物	11(4.82)	26(20.16)	<0.001
子宫脱垂	11(4.82)	1(0.78)	0.02

表2 vNOTES组和TU-LESS组病例的主要结果

	vNOTES(n＝228)	TU-LESS(n＝129)	P值
子宫重量(g),中位数(±IQR)	164.00(±224.00)	176.90(±254.00)	0.58
子宫重量>400 g (%)	31(13.6)	21(16.3)	0.48
总手术时长(min) (±s)	78.21±30.79	112.09±44.05	<0.001
出血量(ml),中位数(±IQR)	50(±10)	50(±50)	0.25
肛门排气时间(±s)	18.80±6.60	36.49±13.71	<0.001
VAS疼痛评分，平均值(±IQR)	0(0～0)	0.5(0～5)	<0.001
术后住院时间(d),中位数(±IQR)	2.31±0.69	3.77±1.57	<0.001
术后镇痛药使用(%)	10(4.39)	20(15.50)	<0.001
并发症(%)	0(0)	0(0)	－
伤口感染(%)	0(0)	2(1.55)	0.13
6周后再次入院(%)	0(0)	0(0)	－

表2 vNOTES组和TU-LESS组病例的主要结果

	vNOTES(n＝228)	TU-LESS(n＝129)	P值
子宫重量(g),中位数(±IQR)	164.00(±224.00)	176.90(±254.00)	0.58
子宫重量>400 g (%)	31(13.6)	21(16.3)	0.48
总手术时长(min) (±s)	78.21±30.79	112.09±44.05	<0.001
出血量(ml),中位数(±IQR)	50(±10)	50(±50)	0.25
肛门排气时间(±s)	18.80±6.60	36.49±13.71	<0.001
VAS疼痛评分，平均值(±IQR)	0(0～0)	0.5(0～5)	<0.001
术后住院时间(d),中位数(±IQR)	2.31±0.69	3.77±1.57	<0.001
术后镇痛药使用(%)	10(4.39)	20(15.50)	<0.001
并发症(%)	0(0)	0(0)	－
伤口感染(%)	0(0)	2(1.55)	0.13
6周后再次入院(%)	0(0)	0(0)	－

图1 228名患者按时间顺序的手术时间

图2 228例vNOTES手术学习曲线注：A.四个阶段手术时间的CUSUMOT值；B-E.每个阶段的最佳拟合曲线。

图3 228例vNOTES离体子宫的重量注：A.按时间顺序排列的228例连续患者离体子宫重量；B.四个阶段患者的平均子宫重量。

表3 患者特征和术后结局的阶段间比较

	阶段Ⅰ(n＝43)	阶段Ⅱ (n＝91)	阶段Ⅲ (n＝26)	阶段Ⅳ(n＝68)	P值
病例号	1～43	44～134	135～160	161～228	－
BMI (kg/m²)	24.01±2.74	24.32±3.46	22.57±2.27	24.06±2.93	0.09
子宫重量(g)	158.92±134.60	195.96±154.25	423.27±338.14	214.30±171.89	<0.001
手术时间(min)	82.81±31.45	72.48±23.66	103.77±45.69	73.18±26.89	<0.001
失血量(ml)	50.00±30	50.00±20	50.00±113	50.00±18	0.01^a
术后住院天数(d)	2.23±0.43	2.52±0.94	2.20±0.41	2.14±0.43	0.12

表3 患者特征和术后结局的阶段间比较

	阶段Ⅰ(n＝43)	阶段Ⅱ (n＝91)	阶段Ⅲ (n＝26)	阶段Ⅳ(n＝68)	P值
病例号	1～43	44～134	135～160	161～228	－
BMI (kg/m²)	24.01±2.74	24.32±3.46	22.57±2.27	24.06±2.93	0.09
子宫重量(g)	158.92±134.60	195.96±154.25	423.27±338.14	214.30±171.89	<0.001
手术时间(min)	82.81±31.45	72.48±23.66	103.77±45.69	73.18±26.89	<0.001
失血量(ml)	50.00±30	50.00±20	50.00±113	50.00±18	0.01^a
术后住院天数(d)	2.23±0.43	2.52±0.94	2.20±0.41	2.14±0.43	0.12

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Comparison of the application of transvaginal natural orifice transluminal endoscopic surgery and trans-umbilical laparoscopic single-site surgery in hysterectomy

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